Kornimate/medical-research-clean huggingface dataset:
non-anesthetized plexus technique for infant (bpbp) mri evaluation

Conditions: Brachial Plexus Palsy Due to Birth Trauma; Injury; Newborn

Summary: the investigators are studying the ability of a novel rapid magnetic resonance imaging (mri) protocol to provide more accurate and earlier information about whether an infant with brachial plexus birth palsy will require nerve surgery.

brachial plexus birth palsy (bpbp) affects approximately 1 in 1,000 newborns, and though the majority of infants regain full function of the affected arm without nerve surgery, those with more severe nerve root injuries will require it. currently, the best way to determine who will need surgery is to measure the trajectory of muscle recovery by serial clinical exams, but the optimal time for nerve surgery (before 3 months of age) is earlier than the time it usually takes to determine whether the infant needs surgery (up to 6 months.) a non-invasive diagnostic test that identifies the more severe injuries that require surgery earlier than serial exams would improve treatment timing, planning, and accuracy, and ultimately outcomes. the investigators have developed a rapid mri sequence with high spatial resolution and soft tissue contrast that does not require sedation or injection of a contrast agent, and that appeared to accurately assess the severity of nerve injury in infants with bpbp in a pilot study. this pilot study demonstrated that the protocol distinguishes infants who ultimately needed surgery from those who recovered spontaneously. the purpose of the current study is to enroll 100 infants at 3 centers (shriners hospital for children northern california, boston children's hospital, and gillette children's hospital) over a 5 year period to validate this imaging protocol as the new "gold standard" to determine whether infants with bpbp need surgery, so that individuals who need it could have surgery earlier when it is more effective, and the parents of the majority who will recover spontaneously could be spared months of worry.

Eligibility criteria:
inclusion criteria: * diagnosis of brachial plexus birth palsy. * age at consent ≤4 months exclusion criteria: * bilateral brachial plexus birth palsy. * age at mri \ 4 months old (patients can be enrolled prior to 28 days of age, but the imaging must occur in the 28 days to 4 months' time period). the lead pi will need to approve the enrollment of a subject who will have the mri after 90 days of age. * concomitant medical conditions that would preclude performance of or confound interpretation of mri or any clinical assessment.
serial pet mpi in patients undergoing cancer treatment

Conditions: Cancer; Chemotherapeutic Toxicity; Coronary Artery Disease; Coronary Microvascular Disease

Summary: this study aims to evaluate the effects of cardiotoxic cancer therapies on myocardial blood flow (mbf) and perfusion in a prospective sample of va patients.

up to 60 patients who will be newly initiating chemotherapy are going to be prospectively evaluated using pet myocardial perfusion imaging (mpi) for chemotherapy-induced cardiotoxicity by quantifying mbf and perfusion. patients will be grouped into 3 categories: 1. patients undergoing chemotherapy with anthracycline containing regimen. 2. patients undergoing chemotherapy with vegf inhibitor containing regimen. 3. patients undergoing chemotherapy with immune check point inhibitor containing regimen. patients will undergo pet mpi at 3 different time points: 1. baseline pet mpi within 1 month prior to initiation of the chemotherapy regimen. 2. pet mpi at the middle of the chemotherapy regimen. 3. pet mpi within 1 month following completion of the chemotherapy regimen. for pet mpi, the investigators will evaluate for abnormalities such as new perfusion defects, decreases in stress myocardial blood flows and decreases in myocardial flow reserves. all study patients will also be analyzed using the following tests: 1. echocardiogram with strain analysis within +/- 1 week of each pet mpi 2. serology - high sensitivity troponin, cardiac c-reactive protein (crp), brain-type natriuretic peptide (bnp), fasting lipid panel, complete metabolic panel, and complete blood count within +/- 1 week of each pet mpi study. 3. 12-lead ecg with each pet mpi study.

Eligibility criteria:
inclusion criteria: * veterans affairs oncology patients who will be initiating chemotherapy * ability to give consent exclusion criteria: * prior chemotherapy * prior coronary revascularization (percutaneous coronary intervention, coronary artery bypass grafting) * anyone with previous invasive or ct (computed tomography) angiogram demonstrating any lesion ≥ 50% stenosis * known cardiomyopathy defined as rest ejection fraction \< 50% * history of heart and/or another organ transplant * pregnancy or breast-feeding status
suncist: a study of calmangafodipir in healthy japanese and caucasian subjects

Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)

Summary: randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (pk) and safety of pp095-01 in japanese and non-asian (eg, caucasian) subjects.


Eligibility criteria:
inclusion criteria: * bmi within 18.0 to 30.0 kg/m2 and body weight not less than 50 kg * blood pressure between 90 and 140 mmhg systolic, and no higher than 90 mmhg diastolic * non-smoker or not smoking for at least 12 months * be first generation japanese (for group 1 only), defined as: 1. born in japan 2. has 2 japanese biological parents and 4 japanese biological grandparents 3. has lived outside of japan for less than 5 years 4. has made no significant changes in lifestyle, including diet, since leaving japan exclusion criteria: * clinically significant abnormal values for hematology, clinical chemistry, urinalysis, physical exam, vital signs, or electrocardiogram at screening * has a history of human immunodeficiency virus (hiv) antibody positive, or tests positive for hiv; has a history of hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv) positive, or other clinically active liver disease, or tests positive for hbsag or anti-hcv at screening. * has a history of drug or alcohol abuse * has previously received calmangafodipir or mangafodipir * welders, mine workers, or other workers in occupations (current or past) where high manganese exposure is likely
the protective effect of pentoxifylline on acute kidney injury

Conditions: Pentoxifylline; Acute Kidney Injury

Summary: acute kidney injury (aki) has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from aki. there had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (ptx) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced aki. we thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of ptx, as compared to placebo, in 200 patients with aki.

acute kidney injury (aki) refers to a clinical syndrome characterized by a rapid (hours to days) decrease in renal function, which is a common and important diagnostic and therapeutic challenge for clinicians. the disorder has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. aki is independently associated with important morbidity and mortality although many efforts have been used in past years. therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from aki. there had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (ptx) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced aki. we thus hypothesized that ptx may have therapeutic value for aki in human. we thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of ptx, as compared to placebo, in 200 patients with aki.

Eligibility criteria:
inclusion criteria: * patients aged between 20 \~ 70 y/o who had admitted for acute kidney injury (renal function decreased within 48hours which meets following criteris: gfr decreased \> 25 %, serum creatinine elevated \> 0.3 mg/dl or 50%、urine amount less than 0.5 ml/kg/hour \> 6 hours). exclusion criteria: * 1. those who had been received regular dialysis or gfr \< 30 ml/min before test. 2. those who with acute bleeding. 3. those who allergy to pentoxifylline or methylxanthine derivatives (such as caffeine, theophylline and theobromine )..
biochemical predictors of delirium in cardiac surgery

Conditions: Postoperative Delirium

Summary: delirium is a common neurologic complication after cardiac surgery occuring in 30-50% of patients. the occurence of this complication is associated with worse outcomes, including prolonged length of stay in the icu and hospital, increased morbidity and mortality. considering great clinical significance of this complication, the search for early predictors of postoperative delirium remains an urgent task. the purpose of this prospective observational study is to test the hypothesis that metabolomic changes before and after cardiac surgery could be served as early predictors of this complication.


Eligibility criteria:
inclusion criteria: * surgery under cardiopulmonary bypass * age \> 60 years * cabg surgery or valve surgery (repair/replacement) exclusion criteria: * urgent surgery * surgery on aorta * combined procedures (cabg+valves) * significant stenosis of carotid arteries * parkinson's disease * liver cirrhosis * use of anticholinergic drugs, antidepressants, antiepileptic or chemotherapy drugs
risk of falling in chronic kidney disease 5

Conditions: Stage 5 Chronic Kidney Disease

Summary: the purpose of this study is to explore the relative importance of the frailty and cardiovascular function as potential exercise-modifiable risk factors for falling in patients receiving haemodialysis.

falls and fall-related injuries in elderly people are common worldwide, and ageing populations will further raise the burden and costs. within the uk, falls have become a major government target, as they have been responsible for increased injuries and hospital admissions in elderly people. the fall rate amongst patients on haemodialysis (hd) is much greater than in the general population. there are many well established risk factors for falling, many of which are commonly present in patients on hd, including severe loss of muscle mass, high levels of inactivity, co-existing medical conditions and a high number of medications. nonetheless, the main cause of health complications and death in chronic kidney disease (ckd) is due to cardiovascular disease. cardiovascular disease may result in suboptimal regulation of blood pressure and heart rate during exercise, dialysis therapy, body transfers, and general activities of daily living. associated symptoms such as dizziness, generalised fatigue, and muscular weakness, are commonly reported and may further predispose patients on hd to balance deficits and falls. despite the evidence of high falls rates in patients on hd and the growing number of elderly patients, falls and their associated risk factors have received little research attention. the aim of this study therefore is explore the relative importance of selected exercise-modifiable risk factors for falling amongst patients on hd.

Eligibility criteria:
inclusion criteria: * 18 years old * able to write/speak fluent english * stable dialysis exclusion criteria: * unstable dialysis and medication treatment * lower limb amputees without prothesis * unstable cardiac condition * suspected or known aneurysm * clinically severe left ventricular outflow obstruction * critical mitral stenosis * critical proximal coronary artery stenosis * critical cerebrovascular stenosis * pregnancy * severe cognitive impairment
examine the effect of repeat inhaled doses of gw870086x on lung function in mild asthmatic male subjects

Conditions: Asthma

Summary: this study was designed to look at safety aspects and effects of repeat inhaled doses of gw870086x in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (copd)


Eligibility criteria:
inclusion criteria: * male subjects aged 18-55 * documented history of bronchial asthma diagnosed at least 6 months ago. * only being treated with short-acting beta-2-agonist therapy e.g. ventolin * documented sensitivity to adenosine mono phosphate (amp) at screening visit * demonstrate repeatable and reproducable response to inhaled amp at the run-in visit exclusion criteria: * any significant illness or disease * history of life threatening asthma * history of respiratory tract infection * subjects who take medication for their asthma, or other conditions, not compatible with this study. * smoker * subjects who are oversensitive to corticosteroids * history of drug or alcohol abuse * donated blood within last 3 months * been involved in another clinical trial during the last 3 months * subjects who work night shifts * subjects who are undergoing de-sensitisation therapy

Keywords: gw870086x asthma crossover repeat dose inhaled
neuroimaging of pavlovian fear conditioning processes in patients with pathological anxiety

Conditions: Post Traumatic Stress Disorder; Anxiety Disorders; Panic Disorder; Social Phobia; Phobia

Summary: the purpose of this study is to use functional magnetic resonance imaging to investigate how the human brain learns to form associations between neutral and emotional stimuli. the study is based on the basic principles of pavlovian conditioning. when someone learns that a neutral stimulus (such as the sound of a bell) predicts an unpleasant stimulus (such as a mild electrical shock), the neutral stimulus takes on the properties of an emotional stimulus. the investigators are interested in the neural processes involved in this learning in people with a clinical anxiety disorder and posttraumatic stress disorder (ptsd).

this study uses functional mri in people with anxiety and stress-related disorders to evaluate the neural correlates of fear conditioning and extinction. during fear conditioning participants see a picture of a face that predicts a mild electrical shock to the wrist. participants then return the next day to the scanner for a test of fear expression 24-hours after fear conditioning. the investigators are simultaneously measuring autonomic arousal in the scanner using measures of skin conductance responses (i.e., sweating). the primary objective of this study is to evaluate different forms of pavlovian fear extinction in patients who suffer from pathological anxiety. the investigators are interested in the effects of extinction and extinction retention over a delay in regions that are known to show abnormalities in anxiety populations. this includes the amygdala, ventromedial prefrontal cortex, and the hippocampus. the study is testing behavioral strategies and does not include any pharmacological manipulations.

Eligibility criteria:
inclusion criteria: 1. male or female volunteer aged 18-50 years old 2. able to understand procedures and agree to participate in the study by giving written informed consent. 3. speaks fluent english. 4. not taking illicit drugs. 5. no history of neurological problems. 6. eligible for mri, including no metal in the body or body piercings that cannot be removed. exclusion criteria: 1. current comorbid axis 1 psychiatric disorder 2. women who are current pregnant or breastfeeding 3. lifetime diagnosis of any psychotic disorder, cognitive suicidal ideation, substance abuse or alcohol dependence, hoarding. 4. medications that act on the central nervous system that interfere with interpretation of the findings (e.g., painkillers, adderall) 5. claustrophobia 6. patients who are unable to comply with procedures or assessments.

Keywords: neuroimaging fear conditioning
effect of prf palatal bandage on pain scores and wound healing after free gingival graft

Conditions: Pain; Wound Healing

Summary: background: free gingival graft (fgg) is used to increase keratinized tissue dimensions. this prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (prf) would improve soft tissue healing of donor sites and decrease pain scores. methods: twenty four patients were planned to receive fgg to augment keratinized tissue dimensions in the mandibular incisors area. donor sites were assigned randomly to receive prf or not by a flip of a coin during the screening visit. patients were instructed to complete a pain study form. the palatal donor area were evaluated for complete wound healing records. these data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.

background: despite a relatively painful surgical procedure, free gingival graft (fgg) is still commonly used to increase keratinized tissue dimensions. this prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (prf) after harvesting a fgg would improve soft tissue healing of donor sites and subsequently decrease pain scores. methods: twenty four patients were planned to receive fgg to augment keratinized tissue dimensions in the mandibular incisors area. enrolled patients received periodontal examination, oral hygiene instructions and full-mouth debridement followed by standardized fgg of similar dimensions. donor sites were assigned randomly to receive prf or not by a flip of a coin during the screening visit. patients were instructed to complete a pain study form to analyze pain scores including vas, nrs-101, vrs-4 as well as three anxiety scales at base line. the palatal donor area were evaluated for complete wound healing based on the degree of color match, tissue texture, and contour of the surgical area compared to preoperative records. these data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.

Eligibility criteria:
inclusion criteria: * lack of keratinized tissue in the mandibular central incisor region exclusion criteria: * smoking * uncontrolled systemic disease that might contraindicate periodontal surgery * severe gag reflex preventing maxillary surgical procedure * inability or unwillingness to provide informed consent
edoxaban treatment in routine clinical practice in patients with venous thromboembolism in korea and taiwan (etna-vte-kor-twn)

Conditions: Venous Thromboembolism

Summary: according to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (vte) recurrence and bleeding. current data for edoxaban are limited to a maximum treatment duration of 12 months. therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent vte) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in an unselected patient population in routine clinical practice.

edoxaban is an orally administered anticoagulant that inhibits coagulation factor xa. it has been approved by the ministry of food and drug safety (mfds) in korea (date: 25th, august 2015) for the: reduction in the risk of stroke and systemic embolism in patients with non valvular atrial fibrillation (nvaf) treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) reduction in the risk of recurrent dvt and pe, and by taiwan food and drug administration (tfda) in taiwan (date: 24th, february, 2016) for the prevention of stroke and systemic embolism in adult patients with nvaf with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (tia). treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) following 5 to 10 days of initial therapy with a parenteral anticoagulant. according to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (vte) recurrence and bleeding. current data for edoxaban are limited to a maximum treatment duration of 12 months. this non-interventional study aims to gather further insight into efficacy (i.e. symptomatic recurrent vte) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in approximately 350 patients in an unselected patient population in routine clinical practice.

Eligibility criteria:
inclusion criteria: * established acute initial or recurrent vte * patients prescribed treatment with edoxaban according to package information before participation in the trial * written informed consent for participation in the study (icf) * not simultaneously participating in any interventional study exclusion criteria: * none

Keywords: non-interventional study real world evidence patients with acute vte treated with edoxaban efficacy/safety
functional electrical stimulation for production of artificial cough

Conditions: Spinal Cord Injuries; Paralysis

Summary: the purpose of the present study is to assess the utility of abdominal muscle stimulation to provide large positive airway pressures and expiratory airflow thus simulating cough. restoration of cough in spinal cord injured patients may reduce the incidence of respiratory complications such as atelectasis, respiratory tract infections and respiratory failure.

cough is a complex defensive respiratory reflex mechanism necessary for the clearance of respiratory secretions and foreign materials. in patients with chronic bronchitis, previous investigations have found that the cough mechanism is the most effective measure to enhance mucous clearance from the lung. patients with cervical and thoracic spinal cord injuries have suffered a loss of the major portion of their expiratory muscles. consequently, they are unable to generate significant positive intrathoracic airway pressures or airflow and have a markedly increased risk of developing pulmonary infections. mechanical methods have been developed to enhance cough production. however, these have resulted in only marginal increases in airway pressure. preliminary studies in our laboratory in animal experiments and those of others in humans have suggested that the abdominal muscles can be stimulated directly by surface electrodes. the purpose of the present study, therefore, is to assess the utility of abdominal muscle stimulation in quadriplegics and paraplegics to simulate cough. a range of stimulus parameters and electrode locations will be assessed to determine optimal stimulus paradigms. airway pressure and expiratory airflow will be used as indices of cough effectiveness. if successful, abdominal muscle stimulation may be a useful tool to restore cough and hopefully reduce the incidence of respiratory complications such as atelectasis and infection in spinal cord injured patients.

Eligibility criteria:
inclusion criteria: * patients with cervical or thoracic spinal cord injury exclusion criteria: * significant cardiovascular disease * active lung disease * pacemaker or other metallic implant * legally incompetent